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Safety and Efficacy Study of DAV132 in Healthy Volunteers

Information source: Da Volterra
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: DAV132 (Device); Moxifloxacin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Da Volterra

Official(s) and/or principal investigator(s):
Xavier Duval, MD, Principal Investigator, Affiliation: CIC Bichat, Paris France


The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

Clinical Details

Official title: Influence of the Administration of DAV132 7.5g Tid for 7 Days on the Fecal Levels of Moxifloxacin During and After a 5-day Oral Treatment With Moxifloxacin 400mg Oad in Healthy Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: The area under the free moxifloxacin concentration-time curve over the period time from beginning of treatment to 16 days after the beginning of treatment.

Secondary outcome: The area under the free moxifloxacin concentration-time curve over the period time from beginning of treatment to 37 days after the beginning of treatment

Detailed description: The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:

- To capture residual concentration of antibiotics in colon without interfering with

their systemic pharmacokinetics parameters.

- To explore the influence of DAV132 to prevent the modification of gut flora due to

antibiotic. In addition, the security and acceptability of DAV132 used during 7 days will be evaluated. The proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy volunteers

- Normal digestive transit, with usually one daily stool.

- Females participating in the study :

must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.

- Having given and signed the written study informed consent prior to undertaking any

study-related procedure.

- Covered by the French Health Insurance system.

Exclusion Criteria:

- Any history or presence of clinically relevant cardiovascular, pulmonary,

gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.

- Contra-indications to fluoroquinolones, or risk factors for adverse events associated

to fluoroquinolones.

- Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase

deficiency should be excluded.

- Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase

deficiency or glucose-galactose malabsorption should be excluded.

- Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or

haemorrhage, recent digestive tract surgery.

- Fecal colonisation by Clostridium difficile.

- Recent history of hospitalisation (within 3 months prior to inclusion).

- Any antibiotic administration within 3 months before inclusion.

- Any vaccination within the last 28 days.

Locations and Contacts

CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard, Paris 75O18, France
Additional Information

Related publications:

Edlund C, Beyer G, Hiemer-Bau M, Ziege S, Lode H, Nord CE. Comparative effects of moxifloxacin and clarithromycin on the normal intestinal microflora. Scand J Infect Dis. 2000;32(1):81-5.

Burkhardt O, Borner K, Stass H, Beyer G, Allewelt M, Nord CE, Lode H. Single- and multiple-dose pharmacokinetics of oral moxifloxacin and clarithromycin, and concentrations in serum, saliva and faeces. Scand J Infect Dis. 2002;34(12):898-903.

Starting date: March 2014
Last updated: June 2, 2015

Page last updated: August 23, 2015

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